This is a randomized, controlled, double-blind, intervention trial of healthy male and female term infants to evaluate the efficacy of the 2 HMOs on beneficially modulating the gut microbiota, gut maturation, gut barrier integrity, immune response, and other developmental outcomes in healthy Chinese infants. The trial consists of 2 randomized formula-fed groups, and a non-randomized breastfed reference group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
262
Starter infant formula will be administered to the participants orally, ad libtium to 6 months, after which they will transfer to a classical follow-up formula (non-trial formula) until the end of the trial (12 months of age).
Starter infant formula will be administered to the participants orally, ad libtium to 6 months, after which they will transfer to a classical follow-up formula (non-trial formula) until the end of the trial (12 months of age).
The International Peace Maternity & Child Health Hospital of China Welfare Institute
Shanghai, China
RECRUITINGBifidobacteria abundance in fecal samples
Bifidobacteria abundance using qPCR technology
Time frame: just prior to 3 months of age
Gut microbiota composition
Relative abundance of beneficial and potentially pathogenic species using next generation sequencing (NGS) technology
Time frame: From enrollment until 12 months of age
Fecal metabolism
Fecal pH analyzed using HPLC as well as targeted or untargeted metabolomics profiling
Time frame: From enrollment until 12 months of age
Fecal metabolism
Short chain fatty acids analyzed using HPLC as well as targeted or untargeted metabolomics profiling
Time frame: From enrollment until 12 months of age
Fecal markers of intestinal immune health
Fecal secretory IgA measured by ELISA
Time frame: From enrollment until 6 months of age
Fecal markers of gut barrier function
Calprotectin measured by ELISA
Time frame: From enrollment until 6 months of age
Fecal markers of gut barrier function
α-1-antitrypsin measured by ELISA
Time frame: From enrollment until 6 months of age
Fecal markers of gut barrier function
Lipocalin-2 measured by ELISA
Time frame: From enrollment until 6 months of age
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Fecal markers of inflammation
Levels of cytokines such as IL-1β measured by ELISA
Time frame: From enrollment until 6 months of age
Fecal markers of inflammation
Levels of cytokines such as IFN-γ measured by ELISA
Time frame: From enrollment until 6 months of age
Fecal markers of inflammation
Levels of cytokines such as TNF-α measured by ELISA
Time frame: From enrollment until 6 months of age
Stool patterns
Stool frequency, consistency, and difficulty in passing stools assessed using a 1-day retrospective stool consistency diary (24-hr recall)
Time frame: From enrollment until 14 days
Stool patterns
Stool frequency, consistency, and difficulty in passing stools assessed using a 3-day prospective collection recorded in the stool consistency diary.
Time frame: From enrollment until 12 months of age
GI symptoms and behaviors
IGSQ-13 Questionnaire
Time frame: From enrollment until 6 months of age
Immune competence
Pediatric Immune System Index score
Time frame: From enrollment until 12 months of age
Infant sleep duration and night-time wakings per 24 hours
Brief infant sleep questionnaire (BISQ)
Time frame: From enrollment until 6 months of age
Infant Health Related Quality of Life
Infant Toddler Quality of Life Questionnaire (ITQoL -SF47)
Time frame: From enrollment until 6 months of age
Growth
Weight (g) and corresponding Z-scores
Time frame: From enrollment until 12 months of age
Growth
Length (cm) and corresponding Z-scores
Time frame: From enrollment until 12 months of age
Growth
Head circumference (cm) and corresponding Z-scores
Time frame: From enrollment until 12 months of age
Growth
Weight gain and corresponding Z-scores
Time frame: From enrollment until 12 months of age
Growth
Length gain, corresponding Z-scores
Time frame: From enrollment until 12 months of age
Physical Examination
Time frame: At enrollment and at 12 months of age
Infant Illness
Infant Illness Diary
Time frame: From enrollment until 12 months of age
Infant illness, infections and medication usage
AEs and Serious Adverse Events (SAEs)
Time frame: From the time the informed consent form has been signed at enrollment infant age less than 3 days until 12 months of age
Medication use (type and duration)
Concomitant medication form and Infant Illness Diary
Time frame: From enrollment until 12 months of age